This invention relates to a drug delivery system which both stores and subsequently affords sterile access to the contents of a drug containing vial. More particularly, this invention relates to a drug delivery system which allows sterile access to a packaged drug, either by the utilization of a syringe or direct insertion of the drug containing vial into a fluid supply source in an I.V. administration system.
Medicaments or drugs normally administered in a health care environment, being flowable substances, are typically packaged in vials whose interior is maintained in a sterile condition. The vials themselves are sealed by a sterile stopper which is eventually pierced by a cannula when it is desired to remove the medicament or drug. Several procedures are required in order to get the drug from the vial and into the body of a patient. Each procedure is time consuming for health care personnel and more importantly each procedure presents a risk of jeopardizing the sterility of the vial, the stopper or the medicament.
If the medicament in a particular vial is a powder the procedures which may jeopardize sterility include adding diluent to the vial to dissolve the powder and then subsequently further diluting the concentrated diluent-medicament solution to the desired strength. When the medicament or drug can be administered directly to a patient, a cannula and syringe assembly may be used to make an injection through the skin of the patient or into a Y-site in an I.V. administration set. If the medicament or drug is of such a strength or potency that it must be administered over a prolonged period of time then the medicament or drug is mixed with a large quantity of diluent and placed into a container which becomes a secondary fluid source in a piggyback I.V. administration system. If there is no primary fluid source in an I.V. administration system the medicament and diluent solution may itself be administered intravenously to a patient.
The problem, therefore, experienced by health care and pharmacy personnel with prior art drug delivery systems is two-fold. First, multiple time consuming procedures are required in order to take the drug from its storage condition to a condition in which it can be properly and safely administered to a patient. Second, each procedure between storage and administration presents a new opportunity for jeopardizing drug stopper or vial sterility. The need exists, therefore, to provide a system by which the possibility of contamination of a drug, the vial and the stopper are minimized between storage and administration.
Nowhere in the art is there found a drug delivery system which minimizes the procedures between storage and administration and simultaneously assures sterility of the drug, the stopper and the vial.
U.S. Pat. No. 2,997,014 discloses enclosing a vial within a separate container for protection against damage, U.S. Pat. No. 3,394,831 discloses the addition of a tear strip to facilitate opening of a protective package surrounding a medicament container. The utilization of a U-shaped stopper to securely lock and unlock the opening in a vial is disclosed in U.S. Pat. No. 2,746,632. Covering the stopper in the vial with a sealing disk to maintain sterility of the stopper is disclosed in U.S. Pat. No. 4,244,478, and formation of a handle or hanger at the base of a container is disclosed in U.S. Pat. No. 3,325,031 to Singier.